A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
PACIFIC-9
A Phase III, Double-blind, Placebo-controlled, Randomised, Multicentre, International Study of Durvalumab Plus Oleclumab and Durvalumab Plus Monalizumab in Patients With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following Definitive, Platinum-Based Concurrent Chemoradiation Therapy
3 other identifiers
interventional
1,051
20 countries
202
Brief Summary
This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 nonsmall-cell-lung-cancer
Started Feb 2022
Longer than P75 for phase_3 nonsmall-cell-lung-cancer
202 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
February 3, 2022
CompletedStudy Start
First participant enrolled
February 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 2, 2030
January 27, 2026
January 1, 2026
4.4 years
January 14, 2022
January 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Surival (PFS)
Progression Free Survival (PFS) as assessed by BICR, per RECIST 1.1.
Up to 5 years after first patient randomized.
Secondary Outcomes (15)
Overall Survival (OS)
Up to 9 years after first patient randomized
Objective response rate (ORR)
Up to 5 years after first patient randomized
Overall survival (OS) at 24 months
Up to 9 years after first patient randomized
Duration of response (DoR)
Up to 5 years after first patient randomized
Progression free survival (PFS) at 6, 12, 18, and 24 months
From date of randomization until 24 months
- +10 more secondary outcomes
Study Arms (3)
Arm A: Durvalumab and Oleclumab
EXPERIMENTALDurvalumab on Day 1 of each 28-day cycle + Oleclumab on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Arm B: Durvalumab and Monalizumab
EXPERIMENTALDurvalumab + Monalizumab on Day 1 of each 28-day cycle for up to 12 months. Placebo infusion will be administered on Day 15 of cycles 1 and 2 only
Arm C: Durvalumab and Placebo
ACTIVE COMPARATORDurvalumab on Day 1 of each 28-day cycle + Placebo on Days 1 and 15 of cycles 1 and 2, then on Day 1 of each subsequent 28-day cycle for up to 12 months
Interventions
Durvalumab IV (intravenous infusion)
Placebo IV (intravenous infusion)
Eligibility Criteria
You may qualify if:
- Participant must be ≥ 18 years at the time of screening.
- Histologically- or cytologically-documented NSCLC and have been treated with concurrent CRT for locally advanced, unresectable (Stage III) disease
- Provision of a tumour tissue sample obtained prior to CRT
- Documented tumour PD-L1 status by central lab
- Documented EGFR and ALK wild-type status (local or central).
- Patients must not have progressed following definitive, platinum based, concurrent chemoradiotherapy
- Participants must have received at least 2 cycles of platinum-based chemotherapy concurrent with radiation therapy
- Participants must have received a total dose of radiation of 60 Gy ±10% (54 Gy to 66 Gy) as part of the chemoradiation therapy, to be randomised. Radiation therapy should be administered by intensity modulated RT (preferred) or 3D-conforming technique.
- WHO performance status of 0 or 1 at randomization
- Adequate organ and marrow function
You may not qualify if:
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥5 years before the first dose of study intervention and of low potential risk for recurrence, adequately resected non-melanoma skin cancer and curatively treated in situ disease, or adequately treated carcinoma in situ or Ta tumours without evidence of disease.
- Mixed small cell and non-small cell lung cancer histology.
- Participants who receive sequential (not inclusive of induction) chemoradiation therapy for locally advanced (Stage III) unresectable NSCLC.
- Participants with locally advanced (Stage III) unresectable NSCLC who have progressed during platinum-based cCRT.
- Any unresolved toxicity CTCAE \>Grade 2 from the prior chemoradiation therapy (excluding alopecia).
- Participants with ≥grade 2 pneumonitis from prior chemoradiation therapy.
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or idiopathic pneumonitis - regardless of time of onset prior to randomisation. Evidence of active non-CRT induced pneumonitis (≥ Grade 2), active pneumonia, active ILD, active or recently treated pleural effusion, or current pulmonary fibrosis - diagnosed in the past 6 months prior to randomization.
- Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (202)
Research Site
San Diego, California, 92123, United States
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New Haven, Connecticut, 06510, United States
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Stuart, Florida, 34994, United States
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Urbana, Illinois, 61801, United States
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New Albany, Indiana, 47150, United States
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Lexington, Kentucky, 40503, United States
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Louisville, Kentucky, 40241, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21201, United States
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Baltimore, Maryland, 21229, United States
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Bethesda, Maryland, 20817, United States
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Grand Rapids, Michigan, 49503, United States
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Duluth, Minnesota, 55805, United States
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Billings, Montana, 59101, United States
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Ridgewood, New Jersey, 07450, United States
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Ithaca, New York, 14850, United States
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Greensboro, North Carolina, 27403, United States
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Cleveland, Ohio, 44124, United States
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Cleveland, Ohio, 44195, United States
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Maumee, Ohio, 43537, United States
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Portland, Oregon, 97239, United States
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Philadelphia, Pennsylvania, 19104, United States
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York, Pennsylvania, 17403, United States
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Sioux Falls, South Dakota, 57105, United States
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Houston, Texas, 77030, United States
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Charlottesville, Virginia, 22908, United States
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Fairfax, Virginia, 22031, United States
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Fredericksburg, Virginia, 22408, United States
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Richmond, Virginia, 23235, United States
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Richland, Washington, 99352, United States
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Spokane, Washington, 99204, United States
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Tacoma, Washington, 98405, United States
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Milwaukee, Wisconsin, 53226, United States
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Box Hill, 3128, Australia
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East Melbourne, 3002, Australia
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Elizabeth Vale, 5112, Australia
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Gosford, 2250, Australia
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Heidelberg, 3084, Australia
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Kogarah, 2217, Australia
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South Brisbane, 4101, Australia
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St Albans, 3021, Australia
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Westmead, 2145, Australia
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Barretos, 14784-400, Brazil
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Belo Horizonte, 30380-090, Brazil
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Florianópolis, 88034-000, Brazil
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Fortaleza, 60336-232, Brazil
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Jaú, 17210-120, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90610-001, Brazil
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Porto Alegre, 91350-200, Brazil
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Recife, 52010-075, Brazil
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São Paulo, 01323-903, Brazil
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Uberlândia, 38408-150, Brazil
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Vitória, 29043-260, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Kingston, Ontario, K7L 2V7, Canada
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London, Ontario, N6A 5W9, Canada
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Mississauga, Ontario, L5M 2N1, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Rimouski, Quebec, G5L 5T1, Canada
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Anyang, 455000, China
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Beijing, 100021, China
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Changchun, 130021, China
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Changsha, 410008, China
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Changsha, 410013, China
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Guangzhou, 510060, China
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Guangzhou, 510062, China
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Guangzhou, 510700, China
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Hangzhou, 310002, China
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Hangzhou, 310022, China
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Hefei, 133500, China
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Hefei, 230031, China
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Kunming, 650118, China
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Linhai, 317000, China
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Nanchang, 330006, China
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Nanning, 530021, China
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Nantong, 226361, China
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Neijiang, 641000, China
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Ningbo, 315100, China
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Shaoguan, 512027, China
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Tianjin, 300060, China
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Wuhan, 430022, China
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Wuhan, 430071, China
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Wuhan, 430079, China
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Zhanjiang, 524001, China
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Zhengzhou, 450000, China
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Zhengzhou, 450008, China
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Zhongshan, 528403, China
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Barranquilla, 080020, Colombia
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Bogota D.C., 110131, Colombia
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Medellín, 050034, Colombia
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Valledupar, 200001, Colombia
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Avignon, 84918, France
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Besançon, 25030, France
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Bordeaux, 33075, France
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Clermont-Ferrand, 63000, France
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Créteil, 94010, France
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Lorient, 56322, France
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Marseille, 13015, France
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Montpellier, 34298, France
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Rennes, 35033, France
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Rouen, 76031, France
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Toulouse, 31059, France
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Villejuif, 94805, France
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Erfurt, 99089, Germany
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Erlangen, 91054, Germany
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Essen, 45147, Germany
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Esslingen am Neckar, 73730, Germany
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Georgsmarienhütte, 49124, Germany
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Gütersloh, 33332, Germany
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Hanover, 30459, Germany
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Oldenburg, 26121, Germany
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Würzburg, 97080, Germany
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Brescia, 25123, Italy
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Florence, 50134, Italy
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Lucca, 55100, Italy
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Meldola, 47014, Italy
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Orbassano, 10043, Italy
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Parma, 43126, Italy
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Pavia, 27100, Italy
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Roma, 00128, Italy
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Himeji-shi, 670-8520, Japan
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Hiroshima, 730-0011, Japan
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Kashiwa, 227-8577, Japan
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Kurume-shi, 830-0011, Japan
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Natori-shi, 981-1293, Japan
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Niigata, 951-8566, Japan
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Osaka, 541-8567, Japan
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Sendai, 980-0873, Japan
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Tokushima, 770-8503, Japan
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Toon-shi, 791-0295, Japan
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Wakayama, 641-8510, Japan
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Lima, 15038, Peru
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Lima, Lima 32, Peru
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Lima, Lima 34, Peru
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Bydgoszcz, 85-796, Poland
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Gdansk, 80-952, Poland
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Koszalin, 75-581, Poland
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Poznan, 60-569, Poland
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Siedlce, 08-110, Poland
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Tomaszów Mazowiecki, 97-200, Poland
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Warsaw, 02-781, Poland
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Lisbon, 1099-023, Portugal
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Lisbon, 1400-048, Portugal
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Lisbon, 1769-001, Portugal
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Lisbon, 1998-018, Portugal
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Loures, 2674-514, Portugal
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Porto, 4200-319, Portugal
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Changwon-si, 51353, South Korea
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Cheongju-si, 28644, South Korea
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Seongnam-si, 13620, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Suwon, 16247, South Korea
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Suwon, 16499, South Korea
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Barcelona, 8003, Spain
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Barcelona, 8035, Spain
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Granada, 18016, Spain
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Madrid, 28034, Spain
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Madrid, 28040, Spain
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Santiago de Compostela, 15706, Spain
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Valencia, 46010, Spain
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Hsinchu, 300, Taiwan
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New Taipei City, 23561, Taiwan
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Taichung, 402, Taiwan
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Taichung, 40705, Taiwan
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Taipei, 11490, Taiwan
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Taipei, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10300, Thailand
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Bangkok, 10700, Thailand
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Hat Yai, 90110, Thailand
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Khon Kaen, 40000, Thailand
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Khon Kaen, 40002, Thailand
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Lampang, 52000, Thailand
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Muang, 22000, Thailand
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Muang, 50200, Thailand
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Mueang, 20000, Thailand
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Naimuang, 30000, Thailand
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Ankara, 06010, Turkey (Türkiye)
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Ankara, 06230, Turkey (Türkiye)
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Ankara, 06800, Turkey (Türkiye)
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Cordaleo, 35575, Turkey (Türkiye)
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Diyarbakır, 21280, Turkey (Türkiye)
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Goztepe Istanbul, Turkey (Türkiye)
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Belfast, BT9 7AB, United Kingdom
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Bristol, BS2 8ED, United Kingdom
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Dundee, DD1 9SY, United Kingdom
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Edinburgh, EH4 2XR, United Kingdom
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London, NW1 2PG, United Kingdom
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London, W6 8RF, United Kingdom
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Middlesbrough, TS4 3BW, United Kingdom
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Poole, BH15 2JB, United Kingdom
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Torquay, TQ2 7AA, United Kingdom
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Truro, TR1 3LJ, United Kingdom
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Wolverhampton, WV10 OQP, United Kingdom
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Haiphong, 180000, Vietnam
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Hanoi, 100000, Vietnam
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Ho Chi Minh City, 700000, Vietnam
Related Publications (1)
Barlesi F, Cho BC, Goldberg SB, Yoh K, Zimmer Gelatti AC, Mann H, Gopinathan A, Bielecka ZF, Newton M, Aggarwal C. PACIFIC-9: Phase III trial of durvalumab + oleclumab or monalizumab in unresectable stage III non-small-cell lung cancer. Future Oncol. 2024;20(29):2137-2147. doi: 10.1080/14796694.2024.2354160. Epub 2024 Jul 18.
PMID: 39023287DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabrice Barlesi, MD
Gustave Roussy, Cancer Campus, Grand Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2022
First Posted
February 3, 2022
Study Start
February 7, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
July 2, 2030
Last Updated
January 27, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.